Procedure for Suspension or Termination of IRB-Approved Research and Administrative Hold

PROCEDURE

Investigator Responsibilities

When an Administrative Hold applies, the Investigator:

Notifies the OIRB of investigator hold to research activities;

Notifies IRB Chair in writing of study activities placed on hold in response to imposition of administrative hold;

Responds promptly to requests by the Chair for additional information;

Contacts the sponsor, if necessary, to assist in obtaining information addressing any questions concerning potential changes in the risk:benefit profile of the protocol;

Continues to submit reportable problems in accordance with POL006, UAB Policy to Ensure Prompt Reporting of Unanticipated Problems to Subjects or Others to the IRB, during the period of the administrative hold.

When a Sponsor-imposed Hold applies, the Investigator:

Forwards a notice of hold or removal of hold to the IRB using PRO148, Procedure for Review of Modifications to Previously Approved Research by the Convened IRB, as soon as possible but not later than 10 working days from notification;

Ceases research activities as specified in the sponsor’s hold until notified by the sponsor that the hold is removed;

Identifies clearly in the amendment submission the reasons for the sponsor’s hold and whether the study was interrupted for logistical purposes (e.g., data analysis, drug shortages) or for potential risks to subjects or others. (Note: Removal of hold due to logistical reasons may be performed using expedited procedures. Removal of hold imposed for changes in potential risks must be reviewed by the convened IRB.);

Continues to submit to the IRB reportable problems in accordance with POL006 during the sponsor-imposed hold.

When Suspension of IRB Approval applies, the Investigator:

May have the opportunity to be heard at suspension proceedings in person or in writing;

Ceases research activities suspended by the IRB until the IRB reinstates approval of the suspended research activities;

Cooperates with the IRB to institute corrective actions as delineated by the IRB;

Notifies sponsor of the IRB imposed suspension and reinstatement;

Notifies affected subjects of the suspension through IRB approved communications;

Develops orderly procedures for withdrawal of affected subjects considering the rights and welfare of the subjects and with IRB approval;

Informs subjects of any follow-up procedures permitted or requested by the IRB following the suspension with IRB approval;

Submits reportable problems to the IRB in accordance with POL006 during the IRB approved follow-up of subjects;

Submits reportable problems to the sponsor during the IRB approved follow-up of subjects.

When Termination of IRB Approval applies, the Investigator:

May be heard at termination proceedings in person or in writing;

Ceases all research activities and notifies sponsor of the IRB-imposed termination;

Notifies affected subjects of the termination through IRB-approved communications;

Develops orderly procedures for withdrawal of affected subjects considering the rights and welfare of the subjects and with IRB approval;

Informs subjects of follow-up procedures permitted or required by the IRB following termination and with IRB approval;

Submits to the IRB reportable problems in accordance with Attachment to POL006and the sponsor during IRB approved follow-up of subjects;

Submits reportable problems to the sponsor during IRB approved follow-up of subjects.

IRB Responsibilities

For Administrative Hold, the IRB Chair:

Receives information that justifies a halt in some or all research such as the occurrence of serious harm to a participant or non-compliance with IRB requirements;

Requests the investigator place one or more research activities on hold such as recruitment, screening/enrollment, interactions or interventions, or follow-up;

Notifies the investigator by telephone and written communication of the request for and extent of the administrative hold;